Kornimate/medical-research-clean huggingface dataset:
a study of bomedemstat (mk-3543) in participants with polycythemia vera (mk-3543-004)

Conditions: Polycythemia Vera

Summary: this study will evaluate the safety, efficacy, pharmacokinetics (pk), and pharmacodynamics of the orally administered lysine-specific demethylase 1 (lsd1) inhibitor bomedemstat, in participants with polycythemia vera (pv). at week 36 of dosing, participants will be assessed for eligibility to receive additional treatment through week 52. participants deriving clinical benefit and safely tolerating bomedemstat will qualify for continued treatment at the investigator's discretion.

with amendment 3, after all ongoing participants have reached 52 weeks of treatment, eligible participants may transition to a bomedemstat extension study if available. with amendment 4, all secondary pk and patient reported outcome measures were designated as exploratory.

Eligibility criteria:
inclusion criteria: * has a diagnosis of polycythemia vera per world health organization (who) diagnostic criteria for myeloproliferative neoplasms * has a bone marrow fibrosis score of grade 0 or grade 1 * has failed at least one standard cytoreductive therapy to lower hematocrit * has a life expectancy \>36 weeks * has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation exclusion criteria: * has an eastern cooperative oncology group (ecog) performance status of 3 or greater * has unresolved treatment related toxicities from prior therapies (unless resolved to ≤ grade 1) * has an uncontrolled active infection * has a known human immunodeficiency virus (hiv) infection or active hepatitis b or hepatitis c virus infection * has evidence of increased risk of bleeding, including known bleeding disorders * is pregnant or lactating

Keywords: polycythemia vera bomedemstat
different models of tracheal catheters are used for female thyroid glands

Conditions: Sore Throat; Tracheal Tubes With an Inner Diameter of 6.0mm; Tracheal Tubes With an Inner Diameter of 6.5mm; Tracheal Tubes With an Inner Diameter of 7.0mm

Summary: objective:compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.methods: investigators enrolled 180 female patients with american society of anesthesiologists (asa) physical status i and iii, aged 18-65 years, and scheduled for elective undergoing thyroid surgery with general anesthesia. the participants were randomly assigned into three groups(n=60 each group):group a: tracheal catheter group with an inner diameter of 6.0mm, group b: tracheal catheter group with an inner diameter of 6.5mm, group c: tracheal catheter group with an inner diameter of 7.0mm.the incidence and severity of postoperative sore throat were recorded in three groups at 1 h, 6 h, 24 h and 48 h after operation.


Eligibility criteria:
inclusion criteria: * female; * thyroid surgery should be performed under general anesthesia (ga) at an appropriate time; * asa grade i-iii; * aged 18-65 years; * bmi less than 35kg/m2 * in line with ethics, patients voluntarily accept this experiment and sign informed consent. exclusion criteria: * reflux esophagitis, preoperative sore throat, chronic pharyngitis, preoperative hoarseness, use of anticoagulants or corticosteroids, high risk of reflux or aspiration, dysphagia, previous oral or pharyngeal surgical intervention, bleeding disorder, severe heart, lung, liver and kidney dysfunction * upper respiratory tract infection occurred within 2 weeks before surgery * unable to insert et (no more than two intubations) * patients with hoarseness or sore throat before surgery * language communication, hearing impairment or brain dysfunction such as stroke, unable to communicate

Keywords: thyroid surgery sore throat tracheal tube
immediate vs delayed cord clamping on newborns

Conditions: Newborn; Umbilical Cord

Summary: the best time of the umbilical cord clamping has not been fully understood. immediate cord clamping (with in 10 seconds after birth) has been standardized practice for many years, while who protocol recommends to wait for 60-90 seconds. but the umbilical cord may still pulse for more than 90 seconds. is it best to wait longer until the pulsing ceased? how the time of umbilical cord will affect the newborn? will the longer time be less umbilical bleeding and shorter departure time of the cord? the hypothesis of this study is: to cut the cord after the pulsing ceased is the best time for cord clamping and will result in better quality of life for the newborn and less cord bleeding and earlier departure time of the cord, that means less infections of the cord.

1. for normal newborn (apgar score over 7), regardless term or preterm,normal birth or cesarean section born: experimental group1: waiting for the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen. control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth. 2. for in case of newborn asphyxia(regardless term or preterm,normal birth or cesarean section born): experimental group2: resuscitate on bed site with the cord unclamped until the umbilical cord ceased pulsing. control group 2-1 clamping and cut the cord within 10 second. and resuscitate the baby after transfer to the irradiation table.

Eligibility criteria:
inclusion criteria: * all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that. exclusion criteria: * still birth

Keywords: umbilical cord clamping neonatal anemia omphalitis
placebo vs. linoleic acid controlled assessment of treatment efficacy in ms

Conditions: Multiple Sclerosis

Summary: several investigations have suggested that polyunsaturated fatty acids may promote therapeutic effects in ms. this pilot study will determine whether omega-6 polyunsaturated fatty acids (pufas),in the form of linoleic acid,can reduce disease activity and prevent disability progression in patients with relapsing ms.this study will seek to measure disease activity as seen on mri scans in addition to measuring relapse rates.

participants who meet inclusion criteria will start placebo treatment by taking olive oil for 2 months. this period will include screening activities including 3 monthly mris. those with 2 enhancing lesions on three placebo run-in period mris will continue in the study and receive omega-6 pufa (linoleic acid) for 6 months. brain mris will be repeated after 4,5, and 6 months after treatment.

Eligibility criteria:
inclusion criteria: 1. relapsing ms 2. treated with fda-approved dosage of interferon-beta (avonex,betaseron,rebif), glatiramer acetate for at least 6 months or no immunotherapy for at least 3 months 3. at least one clinical exacerbation or at least one gadolinium enhancing lesion on brain mri in the past 12 months 4. at least two gadolinium enhancing lesions on three brain mris obtained during the placebo run-in period 5. women of childbearing potential may participate provided that they are using adequate birth control methods for the duration of the study. women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating. 6. willing and able to provide informed consent exclusion criteria: 1. corticosteroids within 1 month prior to screening 2. treatment with other immunotherapies (other than interferon-beta, glatiramer acetate or sporadic corticosteroids) within 3 months prior to screening 3. any significant medical condition or laboratory abnormality which may interfere with the subject's ability to participate in the study, including peptic ulcer disease, avascular necrosis and hepatic insufficiency 4. history of hypersensitivity or intolerability to vegetable oils or their constituents 5. unable to perform any of the required study procedures

Keywords: relapsing multiple sclerosis polyunsaturated fatty acids omega-6 fatty acids
study of wrist fusions with the medartis aptus arthrodesis plate

Conditions: Wrist Arthritis; Wrist Osteoarthritis

Summary: the primary working hypothesis of this study is whether wrist arthrodesis leads to an improvement in functional status in both rheumatoid arthritis and post-traumatic osteoarthritis. functional status will be measured by disabilities of the arm, shoulder and hand (dash) questionnaire no earlier than 1 year after surgery.


Eligibility criteria:
inclusion criteria: * age 18-90 * wrist fusion took place between 2014 and 2022 using aptus 2.5 trilock total wrist fusion plate, medartis at hospital waldfriede * rheumatoid arthritis * post-traumatic osteoarthritis patterns: 1. scapholunate advanced collapse (slac) or 2. scaphoid nonunion advanced collapse (snac) exclusion criteria: * post surgery bone fracture of the same limb * pregnancy, lactation * active malignant tumor

Keywords: wrist fusion,arthrodesis,rheumatoid arthritis,osteoarthritis
radiation therapy plus chemotherapy before surgery with or without chemotherapy after surgery in treating patients with rectal cancer

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug, giving the drugs in different ways, and combining chemotherapy with radiation therapy may kill more tumor cells. purpose: randomized phase iii trial to compare the effectiveness of radiation therapy plus fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin after surgery in patients with locally advanced rectal cancer.

objectives: i. assess the local recurrence rate, cost-benefit ratio, and acute and late toxicity associated with concomitant preoperative radiotherapy and fluorouracil/leucovorin (5-fu/cf) in patients with locally advanced adenocarcinoma of the rectum. ii. compare the relapse rate, survival rate, disease-free interval, and cost-benefit ratio associated with 6 courses of postoperative 5-fu/cf vs. no further treatment in these patients. outline: this is a randomized study. patients are stratified by tumor stage, age, type of surgery, and participating institution. patients are randomly assigned to one of two groups. the first group receives radiotherapy to the tumor over 5 weeks and concomitant fluorouracil/leucovorin for 5 consecutive days on the first and fifth weeks. four to six weeks later, patients undergo complete resection, followed upon recovery by fluorouracil/leucovorin every 4 weeks for 6 courses. the second group receives preoperative chemoradiotherapy followed by surgery, as above, with no postoperative treatment. patients are followed for survival. projected accrual: a total of 774 patients will be entered on this multicenter study.

Eligibility criteria:
disease characteristics: histologically confirmed adenocarcinoma or mucinous adenocarcinoma of the rectum distal limit of tumor no higher than 12 cm from the anal verge on proctoscopy locally advanced (t3-4 m0) tumor by one of the following: partial fixation complete stenosis invasion beyond the muscular stratum on transrectal ultrasound patient characteristics: age: 75 and under performance status: who 0 or 1 hematopoietic: wbc greater than 3,000 platelets greater than 130,000 hepatic: not specified renal: creatinine less than 1.4 mg/dl cardiovascular: no unstable angina no cardiac decompensation other: no prior or concurrent malignancy prior concurrent therapy: not specified

Keywords: stage ii rectal cancer stage iii rectal cancer recurrent rectal cancer adenocarcinoma of the rectum mucinous adenocarcinoma of the rectum
safety of fondaparinux as routine vte prophylaxis in medical icu patients

Conditions: Venous Thromboembolism

Summary: this is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical icu population.

this is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical icu population. we expect the null hypothesis to be proven true. one hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical icu patients to one of two pharmacologic vte prophylaxix treatment arms. (1) primary endpoints include hemoglobin, hematocrit, \& platelet counts. blood product utilization, bleeding complications (any), steady state functional factor xa activity (for post hoc analysis), non-study pharmacologic vte prophylaxis (when estimated clcr \< 30ml/min), and days not treated with study drug or treated with alternative agent secondary/ additional data to be collected include patient demographics, primary \& secondary diagnoses, central venous access, and sequential compression device utilization.

Eligibility criteria:
inclusion criteria: 1. ability or legally authorized representative (lar) to provide informed consent 2. adult who has not had surgery within 10 days, admitted to the sentara norfolk general hospital icu medical teaching services for any reason. exclusion criteria: 1. active or suspected bleeding 2. platelet count less than 100,000 per microliter (mm3) of blood 3. thrombolytic or anticoagulant treatment (including any doses of prophylactic ufh, lmwh or fondaparinux) during the current hospitalization 4. initial estimated clcr \< 30 ml/min as determined by the cockcroft-gault equation 5. initial labs indicative or suggestive of rapidly rising serum creatinine (\>1 mg/dl/day) 6. pregnancy (for medicolegal considerations) 7. patients with or expecting to require an epidural catheter 8. patients who are expected to have an immediate (within 24h) need for surgery

Keywords: venous thromboembolism prophylaxis vte prophylaxis
edinburgh cognitive and behavioural amyotrophic lateral sclerosis screen in norway: a prospective cohort study

Conditions: Amyotrophic Lateral Sclerosis; Cognitive Impairment

Summary: this study evaluate use of a translated norwegian version of the edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen (ecas-n) as an early predictor in car-driving, working and use of advanced life-prolonging therapy.

cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (als). screening of cognitive and behavioral impairment is a distinct recommendation in als-specific health care. however, knowledge in how cognitive impairment shall influence health-care professionals' information given to patients and in decision making is lacking. one of the major challenges in als management is the decision-making on advanced therapy. there is a lack of knowledge in how cognitive impairment in als shall be interfere on complex medical treatment that will affect quality of life or life itself. this means significant implications not only to the als patient and the community, but also the family and especially the spouse. thus, further investigation of the ecas-n and its potential in clinical use is needed. the scale may contribute a more proactive treatment better tailored to individual needs. the objective is to evaluate if the ecas-n can be applied as an early predictor in car-driving, working and use of advanced life-prolonging therapy

Eligibility criteria:
inclusion criteria: * voluntary informed consent * native norwegian speaker exclusion criteria: * great difficulties in writing or reading * comorbid medical history * neurological disorders others than als * psychiatric history of importance to cognitive function

Keywords: amyotrophic lateral sclerosis cognitive predictor
improvement of gait by spinal stimulation in patients with postoperative chronic lumbosciatalgia: pilot study (gaitstim)

Conditions: Failed Back Surgery Syndrome

Summary: the purpose of this study is to explore the changes in objective walking parameters induced by medullary stimulation in patients with fail back surgery syndrome, after chronic stimulation, in comparison with preoperative condition.

after the informed consent signature, a first assessment will be carried out, including: quantified analysis of walking (aqm), felt effort questionnaire, pain questionnaires, functional abilities, limitations, goals and quality of life. the implantation of the spinal cord stimulation system will be performed in two stages: the first stage, the electrode alone will be implanted and connected to an external test stimulator, allowing a one-week stimulation test. if the test is positive (eva pain improvement \> or = 50%), the second step will be to connect this electrode to a spectra wavewriter™ internal stimulator. this stimulator delivers three different stimulation modalities: tonic, microburst and high frequency. the activated initial stimulation mode will be the tonic one. after 3 months of "tonic" stimulation, the patient will be treated successively and in random way by 3 other different stimulation modalities during a week: microburst, high frequency, stopped stimulation (off). the aqm and the different questionnaires will be done again, which will determine which stimulation modality is most beneficial to the patient.

Eligibility criteria:
inclusion criteria: * age \> 18 year old and \< or = 70 year old * patients with chronic neuropathic lumbo-sciatalgia (dn4 score \> or = 4/10) as part of a moderate to severe spinal surgery failure syndrome (eva \>50/100), in who a collegial and multidisciplinary indication of medullary stimulation treatment was chosen. * patients awith social security exclusion criteria: * vulnerable persons * patients who are invalid and unable to perform a quantified walk analysis * contraindication to surgery or anesthesia * patient not able to complete questionnaires * woman of childbearing age without effective contraception

Keywords: spinal cord neurostimulation chronic pain
the chest physiotherapy and breathing exercises management of patients following open heart surgery: a national survey of practice in turkey.

Conditions: Chest Physiotherapy

Summary: chest physiotherapy and breathing exercises are an important non-pharmacological treatment modality in order to prevent and minimize postoperative respiratory complications in patients undergoing open heart surgery. different respiratory techniques are used after cardiac surgery, but there is no opinion about which technique or exercise is effective. the purpose of this study, practical application of chest physiotherapy to patients who have had open heart surgery in turkey and to identify methods of breathing exercises.

in this study, cardiovascular surgery in turkey to employees or physiotherapist who worked in intensive care units was planned as e-mail or by reaching to answer the survey questions via telephone. the universe of study in turkey cardiovascular surgery physiotherapists are all actively working or have worked in intensive care.

Eligibility criteria:
inclusion criteria: * to worked or still working in cardiovascular surgery intensive care units * to answer the survey questions exclusion criteria: * to working or worked in cardiovascular surgery intensive care unit and but not answering questionnaire questions

Keywords: open cardiac surgery breathing exercises chest physiotherapy
evaluation of sloan-charts for assessment of disease progress in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: impairment of visual deficits, in particular contrast acuity and contrast impairment are frequent symptoms in ms. however, visual function is not appropriately covered by the standard tools for clinical assessment, namely, the edss and the msfc. the primary aim of this study is to investigate, whether in ms patients contrast acuity and sensitivity change over a period of two years. secondary aims are the correlation of visual contrast parameters with structural retinal changes and quality of life.


Eligibility criteria:
inclusion criteria: * clinically isolated syndrome or definite ms (relapsing-remitting or secondary progressive course) * written informed consent exclusion criteria: * relapse within the last 30 days * significant cognitive impairment * severely decreased visual acuity * preexisting severe retinal pathology

Keywords: multiple sclerosis visual contrast acuity visual contrast sensitivity sloan charts
study to evaluate efficacy, safety, and tolerability of rgh-706 in prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: rgh-706 is a novel, potent, and orally active mchr1 antagonist drug candidate discovered and being developed by gedeon richter plc. for weight management. this will be the first phase 2, proof-of-concept study using rgh-706 and is the third study in the clinical development program for rgh-706. the aim of this study is to evaluate the efficacy, safety, and tolerability of rgh-706 in patients with prader-willi syndrome (pws).


Eligibility criteria:
age limits: * in united states (usa), minimum age will be 17 years old. * in european union (eu) countries, minimum age will be 18 years old. inclusion criteria: * male or female patients aged ≥17 years in usa at screening or aged ≥18 years in eu at screening * genetically confirmed diagnosis of pws * hq-ct total score ≥14 at screening * body weight ≥40 kg/88 lbs and ≤200 kg/450 lbs * stable body weight * negative pregnancy test for females of childbearing potential and nonlactating at screening. * patients must be able to provide or have a parent or guardian who is able to provide written informed consent and/or assent (as applicable) * patients must have at least 1 consistent and reliable primary caregiver exclusion criteria: * severe psychiatric disorders (eg, schizophrenia, bipolar disorder, or major depressive disorder), recent (within 6 months) * risk of suicide according to the investigator's judgment * uncontrollable diabetes mellitus or diabetes mellitus requiring insulin administration * poorly controlled hypothyroidism or hyperthyroidism * chronic or acute liver disease * history of bariatric surgery procedure * uncontrolled obstructive sleep apnea. * history of malignancy within 5 years of screening * systolic blood pressure (bp) ≥160 mmhg and/or diastolic bp ≥100 mmhg, pulse rate ≥100/min at screening. * use of weight-lowering pharmacotherapy within 6 months prior to screening. * known qt prolongation * clinically relevant laboratory abnormalities * any other condition that, in the investigator's opinion, might indicate that the patient is unsuitable for the study

Keywords: prader-willi syndrome obesity hyperphagia control